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NCT Number: NCT06954103

Mechanisms And Prognosis of Stroke-Heart Syndrome

The incidence of stroke-heart syndrome following acute stroke, which encompasses both acute ischemic stroke and acute intracerebral hemorrhage, is notably high and is strongly associated with increased mortality and poor outcomes in stroke patients. However, the underlying mechanisms remain unclear, and there are currently no effective prevention or treatment strategies. This study aims to elucidate the neuro-humoral mechanisms of stroke-heart syndrome through multimodal imaging and multi-omics blood analysis. Additionally, it seeks to observe the progression of stroke-heart syndrome and its impact on functional outcomes, cognitive abilities, and emotional issues post-stroke. The research is expected to uncover novel blood biomarkers and brain network mechanisms associated with stroke-heart syndrome, providing potential targets and theoretical foundations for pharmacological treatments or physical interventions. Furthermore, it aims to establish a risk early-warning system for major cardiovascular complications post-stroke, enabling early identification, early intervention, and integrated brain-heart management to improve clinical outcomes for stroke patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Bai

CONTACT

[email protected]

+86 15994298517

Chensheng Pan, MD

SUB_INVESTIGATOR

Guo Li, PhD

SUB_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted within 48 hours of onset, confirmed by CT/MRI as having a stroke (including acute ischemic stroke and hemorrhagic stroke).
  • Moderate-to-severe stroke with NIHSS ≥ 5.

Exclusion criteria

  • Previous focal brain injury (such as stroke, brain surgery, traumatic brain injury, etc.).
  • Brain dysfunction caused by other major neurological disorders than stroke (such as brain tumors, epilepsy, Parkinson's disease, etc.).
  • Transient ischemic attack (TIA) and subarachnoid hemorrhage (SAH).
  • History of cardiac diseases (such as coronary heart disease, heart failure, severe arrhythmias, congenital heart disease, cardiac surgery, valvular heart disease, or undiagnosed significant cardiac symptoms).
  • Concomitant systemic diseases such as renal failure (eGFR < 30), autoimmune disorders, severe infections, etc.
  • History of dementia, depression, or other psychiatric disorders.
  • Poor compliance and inability to cooperate with follow-up.

Treatment and study plan

Primary outcomes

  1. blood high-sensitivity cardiac troponin level

    Time frame: within 48 hours and at 72 hours after stroke onset

    a marker of acute myocardial injury

  2. left ventricular ejection fraction

    Time frame: within 1 week after stroke onset

    measured by transthoracic echocardiography; a marker of ventricular dysfunction and heart failure

  3. blood N-terminal pro-brain natriuretic peptide (NT-proBNP) level

    Time frame: within 1 week after stroke onset

    a marker of ventricular dysfunction and heart failure

  4. functional outcome

    Time frame: 3 months and 1 year after stroke onset.

    measured by modified Rankin scale (mRS), a 7-level ordinal scale (scores 0-6) used to assess global disability after stroke. Higher scores indicate worse functional outcome.

  5. death

    Time frame: 1 month, 3 months and 1 year after stroke onset

Secondary outcomes

  1. post-stroke cognitive impairment

    Time frame: 3 months and 1 year after stroke onset.

    measured by Montreal Cognitive Assessement (MoCA), a widely used screening tool designed to detect mild cognitive impairment and dementia. MoCA score range: 0-30, higher scores indicate better cognitive function.

  2. post-stroke depression

    Time frame: 3 months and 1 year after stroke onset.

    measured by Hamilton depression rating scale (HAMD), a widely used clinician-administered tool for assessing the severity of depression. HAMD score range: 0-52. Higher scores indicate higher depression severity.

  3. post-stroke anxiety

    Time frame: 3 months and 1 year after stroke onset.

    measured by Hamilton anxiety rating scale (HAMA), a clinician-administered tool to assess the severity of anxiety symptoms. HAMA score range: 0-56. Higher scores indicate higher anxiety severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Chensheng Pan, M.D.

CONTACT

[email protected]

+8618202738845

Zhou Zhu, MD, PhD

CONTACT

[email protected]

+86 18171081029

Sponsors and collaborators

Lead sponsor

Chensheng Pan

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Acronym: MAP-SHS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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